Does Apple Need FDA Review to Add Medical Monitoring Features to Apple Watch?
Speculation builds as the FDA announced this week that Apple was one of nine companies the agency has approved for a pilot Digital Health Software Precertification program.
September 28, 2017 at 12:14 AM
5 minute read
If Apple wants to add new medical device-like health monitoring features to its Apple Watch, will the company need to go to the Food and Drug Administration (FDA) for review?
The question gained momentum recently with rumors that Apple is trying to develop a device which would let patients check blood sugar by touching their skin rather than using a painful pin prick, according to news reports.
The speculation builds, too, as this week the FDA announced Apple was one of nine companies the agency has approved for a new pilot “Precert” program, known as Digital Health Software Precertification. Under this pilot program, the agency would review the software developer or digital health technology developer on certain criteria, rather than focusing solely on the product. While some details still need to be worked out on the FDA initiative, it is designed to be a time saver.
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